Bronchoscopy oxygenation system

ABSTRACT

A bronchoscopy oxygenation system having a channel for inserting alternately an instrument or fluids and for delivering oxygen to a patient. The system being provided with pressure relief vent and a pressure relief valve for the relief of excessive oxygen pressure. The bronchoscopy oxygenation system may be used during bronchoscopy and with patient suctioning, bronchoalveolar lavage or biopsy. The bronchoscopy oxygenation system is intended to be used with a conventional bronchoscope.

FIELD OF THE INVENTION

The herein disclosed invention finds applicability in the field ofpulmonary medicine: for example in patient diagnosis, aspirating,sampling and therapeutic delivery.

BACKGROUND OF THE INVENTION

Patients who have pulmonary (lung) symptoms may be candidates forbronchoscopies. There are two types of bronchoscopies; therapeutic anddiagnostic. Therapeutic bronchoscopy is to provide a treatment ortherapy, and diagnostic is to aid in the diagnosis of an underlyingcondition. The bronchoscope is attached to a light source and advancedthrough the nares or mouth of the patient. Some bronchoscopes allow thepulmonologist to view the placement of the tip of the bronchoscope on amonitor from a video chip, and other models have an eye piece forviewing. Local anesthetics are often administered through thebronchoscope as it is advanced through the posterior pharynx and intothe lungs. With direct visualization and manipulation of the tip withdirectional control, the vocal cords are identified and the instrumentadvanced into the trachea. Because of protective airway reflexes and theunpleasant nature of the procedure, the patient is likely to havereceived sedative medications that will decrease the respiratory drive.The respiratory rate will be decreased and the depth will be shallow.Consequently, oxygen delivery to the patient is reduced.

Once the bronchoscope is within the pulmonary system, it isintermittently advanced and withdrawn with directional control to accessdesired portions of the patient's lung. Diagnostic modalities affordedby this procedure include visualization of the trachea, bronchi, andbronchioloes for identification of abnormal tissue or secretions, aswell as the ability to obtain biopsy specimens for laboratory analysisof tissue identification. Biopsy specimens are obtained by passing abiopsy forceps though the channel and excising a piece of tissue.Fluoroscopic x-ray guidance can be used intermittently throughout thisprocedure to aid in confirmation of the placement of the tip of theinstrument.

The problem that is addressed with the new device of this invention isthe problem of hypoxemia in patients who are having bronchoscopies.Hypoxemia is defined as reduced levels of oxygen in the blood and can bedetermined, measured, and quantified by pulse oximitry. Pulse oximitryis a standard monitor that measures the saturation of the oxygencarrying hemoglobin molecule.

In view of the problem of hypoxemia, there is a need in the medicalfield for a bronchial oxygenating system which is easy and safe to use;and when used along with a bronchoscope will provide oxygen through achannel of the bronchoscope when that channel is not in use.

Patent Literature

Lorenzen (U.S. Pat. No. 5,735,271) teaches a closed ventilation systemapparatus which allows multiple access to the respiratory system throughone or more access ports to ventilate the lungs with a gas or gases; toaspirate, oxygenate and visually inspect the respiratory system and/ortake tissue samples. The herein disclosed system is unique in being anopen, rather than a closed ventilation system. In addition Lorenzen doesnot show a pressure sensitive relief valve or a method of reducingstandard hospital pressure through a controlled venting prior to patientapplication.

Bayron (U.S. Pat. No. 5,746,199) teaches a device with an endotrachealtube having attached thereto having several entry ports.

Urrutia (U.S. Pat. No. 5,817,068) teaches a plurality of feeds to a mainconduit. Urrutia is directed to the use of fluids rather than oxygen.

Wood (U.S. Pat. No. 5,766,211) is for a device with a canal with athree-way valve for feed into the canal. Wood is directed to the use offluids rather than oxygen, and does not show a pressure relief valve ora method of reducing standard hospital pressure through a controlledventing prior to patient application.

Akiba (U.S. Pat. No. 6,425,535) is for a fluid supplying apparatus for acleaning the observation window of an endoscope.

Socaria (U.S. Pat. No. 5,329,921) discloses an endotracheal deviceallowing for the performance of various medical procedures whilemaintaining continuity of respiration.

OBJECTS OF THE INVENTION

A main object of the invention is to produce a bronchoscopy oxygenationsystem that is simple and easy to use.

A further object of the invention is to produce a device which is easyfor the pulmonologist who may also be providing conscious sedation touse.

An important object of this invention is to produce a device which isable to safely supply oxygen to the patient and is safe for the doctorto use.

Another important object of the invention is to produce a device whichcan be conveniently used along with a conventional bronchoscope.

These and other objects of the present invention will become apparentfrom a reading of the following specification taken in conjunction withthe enclosed drawings.

SUMMARY OF THE INVENTION

The herein disclosed invention is directed to a new bronchoscopyoxygenation system, the goal of which is to deliver oxygen directly tothe lungs of patients during therapeutic and diagnostic bronchoscopy inorder to reduce hypoxia or hypoxemia during the procedure. Hypoxia isderived from three main causes: First, during bronchoscopy, patients aregiven sedative medications which decrease their respiratory effort, soless oxygen is delivered to the lung. Second, the size of thebronchoscope which may be large compared to the size of the openingbetween the vocal cords can create a mechanical obstruction impedingoxygen delivery. The third and most significant cause of hypoxia is theelimination of air and oxygen from the lungs during suctioning performedto remove secretions and improve visualization as well as suctioning forbronchoalveolar lavage. These factors combine to place these patients atrisk for complications related to depressed levels of oxygen in theirblood.

The bronchoscopy oxygenation system of this invention is particularlyuseful in those surgical situations in which the patient is susceptibleof receiving reduced oxygen during the procedure. Surgical procedures inwhich the system can be used are for example:

Bronchoalveolar lavage which is a technique that can be both diagnosticand therapeutic in nature. In this process, fluid is administeredthrough the channel into the lung airways and then recovered andcollected with the use of suction which is attached to the channel ofthe bronchoscope. This process can be of diagnostic value as the fluidwill contain cells from the patient's lung which can be analyzed in thelaboratory for tissue identification. In addition, bronchoalveolarlavage can be a therapeutic technique by removing excess and harmfulsecretions that are found in the bronchoalveolar system. Improved flowand respiratory gas exchange can result following this technique.

Obtaining of tissue specimens. Biopsy specimens are obtained by passinga biopsy forceps through the channel and excising a piece of tissue.Fluoroscopic x-ray guidance can be used intermittently throughout thisprocedure to aid in confirmation of the placement of the tip of theinstrument.

Suctioning to remove fluids for laboratory analysis or to removesecretions that interfere with visualization. Suctioning is performed toobtain fluid and secretions as determined by the needs of diagnosticmodalities or treatment options. In addition, suctioning isintermittently and frequently performed throughout the procedure tofacilitate visualization by the pulmonologist, as excess secretionswithin the lung can obscure visualization during the procedure. Thissuctioning actively removes oxygen from within the lung, further leadingto reduced oxygen delivery to the respiratory gas exchange membranes andresulting in hypoxemia.

In using the bronchoscopy oxygenation system of the invention along witha bronchoscope, the functions of the bronchoscope are not impeded. Theprimary intent of the design of the bronchoscopy oxygenation system ofthis invention is to utilize the single channel of a bronchoscope toprovide oxygen at times when the primary channel is not otherwise inuse. This channel can be accessed through the biopsy valve and currentlyhas three functions. It can be used to obtain tissue biopsies by passinga biopsy forceps down the channel. The channel can be used to administerfluids such as saline into the lungs to combine with the fluid andsecretions in the lung for bronchoalveolar lavage. The channel can beused for suctioning to remove fluids for laboratory analysis or toremove secretions that interfere with visualization. The inventionproposes using this channel for the purpose of administering oxygen.Most of the time during bronchoscopy, this channel is not used forbiopsies, lavage or suctioning. This provides an opportunity to passoxygen through the bronchoscope to be delivered directly into the lungsat the distal tip of the instrument. The bronchoscopy oxygenation systemof the invention is an open system rather than a closed system. A closedsystem is one in which there is a seal preventing communication betweenthe system and the atmosphere. The closed system is generally used whenpatient can no longer breathe on his own. In the open system, no sealingis present between the patient's respiratory system and the oxygensupply means.

The simplicity of the brochoscopy oxygenation system of the invention isadvantageous in all settings. The new design bronchoscopy oxygenationsystem utilizes a means that will allow for the safe administration ofoxygen and still allow biopsies, lavage or suctioning. The system allowsfor a shared function of the channel in a bronchoscope. Oxygen can beadministered from a standard oxygen flow meter and delivered to patientfrom the distal tip of the device. The oxygen flow can be interruptedwhen necessary for bronchoalveolar lavage or to obtain a biopsyspecimen, but could continue during suctioning. The oxygen flow can beinterrupted by turning the stopcock, which allows access to the biopsyvalve for the other purposes. Interruption of oxygen flow creates asafety hazzard, as the oxygen supply tubing will be holding pressureequal to the oxygen outlet pressure of 50 psi. When this pressure isallowed to access a syringe, the plunger becomes a forceful projectilethat is of concern for personnel. If the pressure is allowed to passthrough the bronchoscope, it may cause patient harm from barotrauma.This safety issue has been resolved by the use of a pressure relief ventdesigned to reduce standard hospital pressure (50 psi) to a level thatwould be safe for patient application, and an additional backup safetypressure relief valve built into the device. The pressure relief valveis set at 40 cm of water which will provide safety to the patient fromany surge in pressure. The invention could consist essentially of thesystem as herein defined.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the Bronchoscopy Oxygenation System ofthis invention.

FIG. 2 is a cross-section view thereof taken along lines 2-2 of FIG. 1.

FIG. 3A is a perspective view of the stopcock.

FIG. 3B is a cross-section taken along lines 3B-3B of FIG. 3A.

FIG. 3C is a perspective of the stopcock taken at a slightly differentangle from FIG. 3A.

FIG. 3D is a view of the channel arrangement of the stopcock position ofFIG. 3A.

FIG. 4A is a perspective view of the stopcock.

FIG. 4B is a cross-sectional view of the stopcock taken along lines4B-4B.

FIG. 4C is a perspective view of the stopcock similar to FIG. 4A.

FIG. 4D is a cross-sectional view of the channel arrangement of thestopcock position of FIG. 4A.

FIG. 5A is a cross-sectional view of a channel arrangement of thestopcock position that is not utilized in this design.

DESCRIPTION

Referring to FIG. 1, the bronchoscopy oxygenation system of the hereindisclosed invention 10 has an oxygen entry orifice 12 and a pressurerelief vent 14, feeding to a pressure relief valve 16 which, in turn, isattached to a stopcock housing 18, the top 19 swivels and the bottom 21is fixed. Through the stopcock housing 18 runs an instrument insertionchannel 20 having a proximal end 22 and a distill tip 24. Attached tothe stopcock housing 18 is top 19 having stop handle 26 and plain handle27. Stop handle 26 has a stop tab plate 42 attached thereto and isintended to engage arrest tubs 44 and 45 (FIG. 3C) for the purpose ofproperly aligning channels of the stopcock, as will be explained. Handle27 has no stop tab and functions simply as a handle.

There are two possible positions of the stopcock. FIGS. 3A-3D illustratethe instrument access position. In the access position the stopcock isturned so the stop tab plate 42 of stop handle 26 is against arrest tab44. FIGS. 4A-4D illustrate the standard or oxygen access position. Inthe standard position the stop tab 42 of stop handle 26 is againstarrest tab 45. These two stopcock positions can most easily be seen bycomparing FIG. 3C with FIG. 4C.

The instrument access position (FIGS. 3A-3D) functions to allow thestopcock channels to align with the instrument insertion channel 20 anddistal end 24 to allow for the passage of an instrument or fluids. InFIGS. 3A and 3B, the crossed dashed lines show the position of thehandles and the arrows show the direction and degree of turn of thehandles.

The standard position (oxygen) (FIGS. 4A-4D) is created by turning thestopcock handles 26 and 27 90° which lines up the channels to allow forthe passage of oxygen. In FIGS. 4A and 4B, the crossed dashed linesacross the stopcock show the position of the handles and the arrow inFIGS. 4A and 4B show the direction in which the handles are turned aswell as the degree of turn. In the standard position oxygen is suppliedthrough the path entry orifice 12, tube 38, reservoir housing 16, tube40, leading to stopcock entry 46 and then paths 52 and 51 (FIGS. 1, 4B,4D) and then to distal end 24.

Referring to FIG. 2, contained in the reservoir housing 16 is a pressureretaining ball 30 and a pre-loaded spring 32 forming a backup safetypressure relief valve. When the backup safety pressure relief valve isactivated by an excess of pressure of oxygen, the excess pressure willcause pressure retaining ball 30 held in place by pre-loaded spring 32to lift from valve seat 33 and allow oxygen to vent to the outsidethrough vent opening 36. Also, shown in FIG. 2 is the stopcock 18 havingbundle 27, stop plate handle 26 with stop tab 42 and arrest bumper 44(not shown) all in top 19 of the stopcock 18. The position of thestopcock 18 allows passage of oxygen from tube 40 to stopcock entry 46and to channel members 52 and 51 (FIG. 4D).

With reference to FIG. 1, in operation, oxygen at 50 psi (standard inoperating rooms) enters the devise 10 through standard neoprene tubing(not shown) at entry orifice 12. The pressure relief vent 14 is sized tobleed off pressure to 40 cm of water bin will allow airflow ofapproximately 3 liters per minute through the device. Oxygen then flowsthrough the reservoir 16 and through the stopcock 18 and channels 52 and51 flowing out of the tip 24 which is inserted into the biopsy port of abronchoscope (not shown). In the reservoir housing 16 there is a backupsafety pressure relief valve, which consists of a pressure retaining aball 30 and a pre-loaded spring 32 which when activated will open andvent through opening 36. The activation event of a surge of oxygenpressure greater than 40 cm of water will cause the pressure retainingball 30 to leave valve seat 33 to vent.

The pressure relief vent 14 and pressure relief valve will function inboth the access and standard positions to prevent excessive oxygenpressure build-up within the system.

With reference to FIGS. 3A-3D and 4A-4D the two stopcock positions areshown which place the device in the access (instrument) or standard(oxygen) positions respectively.

With reference to FIGS. 3B and 4B, a cross section of the stopcock isshown. Particularly note the positions of arrest tabs 44 and 45 whichare to bump against stop plate 42 to align the stopcock for the accessand standard positions respectively (best shown in FIGS. 3C and 4C).

With reference to FIG. 3D, there is schematically shown the accessposition for the stopcock. This illustrates the position of the stopcockto allow the passage of an instrument or fluids while in the accessposition through entry 47 along path 50 and 52 to exit 48 to tube 24.There is no oxygen flow through the stopcock in the access position. Thearrow indicates the direction an instrument or fluids would take whilein the access position.

In FIG. 4D the arrow shows the path of oxygen through the stopcock whilein the standard position. The oxygen path is through entry 46 alongchannel paths 52 and 51 to exit 48 and tube 24.

There is another theoretical position of the stopcock shown in FIG. 5A.This would allow the passage of both an instrument and oxygen. Thispossible position was excluded form this design for practical clinicalconsiderations. The arrows show the path that an instrument and oxygenwould take.

Detailed Description of Use

The procedure for using the bronchoscopy oxygenation system will be toinsert the device into the biopsy port of a bronchoscope. The oxygentubing will be connected from an oxygen flow meter to the device. Theflow meter will be adjusted to approximately 10 liters of oxygen perminute. The stopcock position will initially be in the standard position(oxygen) (FIG. 4A-4D). When bronchoalveolar lavage is performed ortissue biopsies are obtained, the stopcock will be placed in the accessposition (FIG. 3A-3D). Once the lavage or biopsies are completed, thestopcock will be returned to the standard position (FIG. 4A). Thestopcock can be rotated 90 degrees to configure the device in either theaccess or standard position. In the access position a standard 2 mmbiopsy instrument can be inserted or bronchoalveolar lavage performedwithout the need to remove the device from a bronchoscope

The bronchoscopy oxygenation system can be employed with the stopcock inthe standard or access positions as described. The standard positionwould be in use in the majority of times. This position allows fordelivery of oxygen through the bronchoscope and would have the thirdaccess port of the stopcock closed. This position can also be utilizedduring suctioning.

In the suctioning mode, the suction is connected to a bronchoscope in acontinuous fashion. This port has an internal connection to the singlechannel of the bronchoscope and is made to be continuous when thepulmonologist depresses a button on the bronchoscope. When this buttonis not depressed, the reduced barometric pressure of the suction isisolated from the single channel. This configuration allows the suctionto be used with the bronchoscopy oxygenation system of this invention ineither the standard or access positions.

The access position is employed while obtaining tissue biopsies, duringbronchoalveolar lavage, or when other fluids such as local anestheticsare administered. In this position there is no oxygen flow through thechannel. In practical use, the percentage of total procedural time inthis position is minimal.

In both the standard and access positions the pressure relief vent andthe backup safety pressure relief valve will ensure a safe environmentfor both the patient and medical team.

Advantages to using the system of the invention are:

The system can be used during many pulmonary medicine proceduresinvolving the lungs or bronchi where there is reduced oxygen at therespiratory gas exchange membranes in patients having bronchoscopies.The bronchoscopy oxygenation system of this invention will solve thisproblem by administering oxygen through the channel directly into thelungs. This oxygen delivery will be independent of reduced patientrespiratory drive from intravenous medications, and also independent ofthe mechanical obstruction at the vocal cords created by thebronchoscope.

The bronchoscopy oxygenation system has taken into consideration safetyand has built-in safety features. Barotrauma to the lungs is apotentially serious consideration. The system has to be able to deliveran adequate flow of oxygen through a bronchoscope so as to aid inoxygenation of the patient, while limiting the pressure of deliveredgasses to avoid barotrauma. This required knowledge of oxygenutilization and pulmonary physiology. These considerations were inherentin the final design and a redundant system for pressure relief wasengineered. An additional consideration was the safety of personnel. Thewall source of oxygen is delivered at a pressure of 50 pounds per squareinch. This source needed to be adapted so oxygen could be delivered tothe patient in a manner that was safe for both the patient and healthcare personnel.

Obviously, many modifications may be made without departing from thebasic spirit of the present invention. Accordingly, it will beappreciated by those skilled in the art that within the scope of theappended claims, the invention may be practiced other than has beenspecifically described herein.

1. An open bronchoscopy oxygenation system comprising, a) an orifice forreceiving oxygen joined with, b) a reservoir housing containing apressure relief valve, to prevent excessive oxygen pressure, c) astopcock attached to an oxygen passage for receiving oxygen and furtherattached to an instrument passage for receiving an instrument, and withthe stopcock being supplied a handle controlling the flow through theoxygen passage and instrument passage, thus allowing for the passage ofoxygen and/or an instrument through said oxygen passage and/orinstrument passage, and d) with the position of the stopcock allowingfor the passage of either oxygen, an instrument or fluids to a patientsuch that the patient may be safely treated.
 2. The open bronchoscopyoxygenation system of claim 1 wherein there is a pressure relief ventprovided between the orifice for receiving oxygen and said pressurerelief valve.
 3. The open bronchoscopy oxygenation system of claim 1wherein the stopcock is supplied with a handle and a stop-tabarrangement wherein the stopcock can be turned in a direction allowingfor passage of oxygen or the passage of an instrument.
 4. A method ofperforming bronchoalveolar lavage in a patient employing an openbronchoscopy oxygenation system comprising, a) an orifice for receivingoxygen joined with, b) a reservoir housing containing a pressure reliefvalve, to prevent excessive oxygen pressure, c) a stopcock attached toan oxygen passage for receiving oxygen and further attached to aninstrument passage for receiving an instrument, and with the stopcockbeing supplied with a handle controlling the flow through the internalpassages, thus allowing for the passage of oxygen through the oxygenpassage and/or the passage of an instrument through the instrumentpassage, and d) with the stopcock being attached to a passage runningfront said stopcock allowing for the passage of either oxygen, aninstrument or fluids to a patient such that the patient may be treated,and e) with the method steps comprising the steps of supplying oxygen tothe patient through said oxygen passage and turning the stopcock andperforming bronchoalveolar lavage through said instrument passage. 5.The method of claim 4 wherein the open bronchoscopy oxygenation systemis provided with a pressure relief vent between the orifice forreceiving oxygen and said pressure relief valve.
 6. A method ofobtaining a tissue specimen from a patient comprising employing abronchoscopy oxygenation system comprising, a) an orifice for receivingoxygen joined with, b) a reservoir housing containing a pressure reliefvalve, to prevent excessive oxygen pressure, c) a stopcock attached toan oxygen passage for receiving oxygen and further attached to aninstrument passage for receiving an instrument, and with the stopcockbeing supplied with a handle controlling the flow through the oxygenpassage and instrument passage, thus allowing for the passage of oxygenand/or an instrument through said oxynen passage and/or instrumentpassage, and d) with the position of the stopcock allowing for thepassage of either oxygen, an instrument or fluids to a patient such thatthe patient may be safely treated, and e) with the method stepscomprising the steps of alternately supplying oxygen to the patientthrough said oxygen passage and turning the stopcock to perform a biopsythrough said instrument passage with a biopsy forcep and in that waypreventing hypoxemia in said patient while said tissue specimen isobtained.
 7. the method of claim 6 wherein the open bronchoscopyoxygenation system is provided with a pressure relief vent between theorifice for receiving oxygen and said pressure relief valve.
 8. A methodof suctioning of a patient comprising employing an open bronchoscopyoxygenation system comprising, a) an orifice for receiving oxygen joinedwith, b) a reservoir housing containing a pressure relief valve, toprevent excessive oxygen pressure, c) a stopcock attached to an oxygenpassage for receiving oxygen and further attached to an instrumentpassage for receiving an instrument, and with the stopcock beingsupplied with a handle controlling the flow through the oxygen passageand instrument passage, thus allowing for the passage of oxygen and/oran instrument through said oxygen passage and/or instrument passage, andd) with the position of the stopcock allowing for the passage of eitheroxygen, an instrument or fluids to a patient such that the patient maybe safely treated, and e) with the method steps comprising the steps ofaltemately supplying oxygen to the patient through said oxygen passageand turning the stopcock and performing suctioning through saidinstrument passage and in that way preventing hypoxemia in said patientwhile performing suctioning.
 9. The method of claim 8 wherein the openbronchoscopy oxygenation system is provided with a pressure relief ventbetween the orifice for receiving oxygen and said pressure relief valve.10. An open bronchoscopy system comprising: a) an orifice for receivinga gaseous substance; b) a pressure relief vent coupled between theorifice and a passage for the gaseous substance; c) a stopcock coupledto the passage, and further coupled to an instrument passage to receivean instrument, wherein the stopcock is configured with a handle tocontrol a flow through the passage and instrument passage, wherein thestopcock is configured such that the position of the stopcock is topermit the passage of either the gaseous substance or a non-gaseoussubstance to a patient.
 11. The bronchoscopy system of claim 10, whereinsaid non-gaseous substance comprises an instrument or a fluid.
 12. Thebronchoscopy system of claim 10, wherein said gaseous substancecomprises oxygen.
 13. The bronchoscopy system of claim 10, wherein thestopcock includes a handle and a stop-tab arrangement to permit thestopcock to be turned in a direction allowing for passage of the gaseoussubstance or a direction allowing for the passage of a non-gaseoussubstance.
 14. The bronchoscopy system of claim 10, further comprising areservoir coupled to the pressure relief vent and arranged to receivethe gaseous substance.
 15. The bronchoscopy system of claim 14, whereinthe reservoir comprises a pressure relief valve.